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Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 (EVIDENS)

Primary Purpose

Diabetes Mellitus, Type 2, Glucose Intolerance, Vitamin D Deficiency

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Vitamin D3

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
BMI ≤ 32 kg/m2.
HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
Fasting plasma glucose < 9 mmol/l
S-25-OH-vitamin D3 < 75 nmol/l.

Exclusion Criteria:

Treatment with any vitamin D preparation.
Regular sun-bathing in solarium.
Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
Sarcoidosis or other granulomatous disease.
Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
Impaired hepatic function.
Impaired renal function
Cardiac disease defined as:
- Unstable angina pectoris
- Myocardial infarction within the last 6 months
- Congestive heart failure NYHA class III and IV
Cerebral stroke within the last 6 months.
Anti-diabetic medication of any kind.
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

Sites / Locations

Dpt of Endocrinology, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Beta cell function

Assessed by hyperglycemic clamp investigation

Secondary Outcome Measures

Insulin sensitivity

Assessed by hyperglycemic clamp investigation

Glucose tolerance

Assessed by OGTT

Hypercalcemia

Full Information

NCT ID

NCT01497132

First Posted

December 20, 2011

Last Updated

September 9, 2014

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01497132

Brief Title

Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2

Acronym

EVIDENS

Official Title

Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Glucose Intolerance, Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Vigantol oil

Intervention Description

Oral drops 30000 IU weekly

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

Beta cell function

Description

Assessed by hyperglycemic clamp investigation

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Insulin sensitivity

Description

Assessed by hyperglycemic clamp investigation

Time Frame

8 weeks

Title

Glucose tolerance

Description

Assessed by OGTT

Time Frame

8 weeks

Title

Hypercalcemia

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT. BMI ≤ 32 kg/m2. HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC). Fasting plasma glucose < 9 mmol/l S-25-OH-vitamin D3 < 75 nmol/l. Exclusion Criteria: Treatment with any vitamin D preparation. Regular sun-bathing in solarium. Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l. Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l. Sarcoidosis or other granulomatous disease. Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin. Impaired hepatic function. Impaired renal function Cardiac disease defined as: Unstable angina pectoris Myocardial infarction within the last 6 months Congestive heart failure NYHA class III and IV Cerebral stroke within the last 6 months. Anti-diabetic medication of any kind. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Wagner, M.D

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dpt of Endocrinology, Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

26786573

Citation

Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19.

Results Reference

derived

PubMed Identifier

25835492

Citation

Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015.

Results Reference

derived

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Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2

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